Stents, systems, and methods for gastrointestinal tract treatment

ABSTRACT

The present disclosure relates generally to stents, systems, and methods for gastrointestinal treatment. In some embodiments, a stent may include a tubular scaffold having a first end opposite a second end, wherein a lumen extends between the first and second ends. The tubular scaffold may include a flared section and a medial section extending from the flared section, wherein a first diameter of the flared section is greater than a second diameter of the medial section. The stent may further include a liner extending partially along a surface of the tubular scaffold, wherein the liner is spaced from an anchoring region of the flared section to promote tissue ingrowth with the flared section.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of and claims the benefit of theearlier filing date of U.S. Pat. Application No. 16/930,411, filed onJul. 16, 2020, which claims the benefit of priority under 35 U.S.C. §119to U.S. Provisional Pat. Application 62/875,267, filed Jul. 17, 2019,which applications are hereby incorporated herein by reference in theirentireties and for all purposes.

FIELD

The present disclosure relates to implantable medical devices and, moreparticularly, to stents, systems, and methods for gastrointestinal tracttreatment.

BACKGROUND

Implantable medical devices, such as expandable stents, may be designedto provide a pathway for digested material, blood, or other fluid toflow therethrough following a medical procedure. Further, someimplantable medical devices may incorporate features that aid in fistulatreatment, bypass procedures, and/or anastomosis treatment. Theseimplantable medical devices may include radially or self-expandingstents, which may be implanted transluminally via an endoscope.Additionally, some stents may be implanted in a variety of body lumenssuch as the esophageal tract, the gastrointestinal tract (e.g., theintestine, stomach, and the colon), tracheobronchial tract, urinarytract, biliary tract, vascular system, etc.

In some stents, the compressible and flexible properties that assist instent positioning may also result in stent migration. For example,stents that are designed to be positioned in the esophageal orgastrointestinal tract may have a tendency to migrate due toperistalsis, which is an involuntary constriction and relaxation of themuscles of the esophagus, intestine, and colon. Additionally, thegenerally moist and inherently lubricious environment of the esophagus,intestine, colon, etc., further contributes to the tendency for stentsto migrate after deployment. One approach to reduce stent migrationincludes exposing bare metal portions of the stent to tissue of the bodylumen. The stent scaffold may provide a structure that promotes tissueingrowth therewith to promote a hyperplastic response.

Additionally, some stents may be later removed from, or re-positionedwithin, the body lumen post-deployment. One approach to reduce the forcenecessary to remove stents includes providing a covering over a portionof the stent, thereby creating a physical barrier between the body lumenand the outer surface of the stent to reduce tissue ingrowth. However,covered stents may be more prone to migration than bare stents, asdiscussed above.

SUMMARY

The present disclosure in its various embodiments relates generally tostents, systems, and methods for gastrointestinal treatment. In one ormore embodiments, a stent, may include a tubular scaffold having a firstend opposite a second end, wherein a lumen extends between the first andsecond ends. The tubular scaffold may include a flared section, a medialsection extending from the flared section, wherein a diameter of theflared section is greater than a diameter of the medial section, and aliner extending partially along a surface of the tubular scaffold,wherein the liner is spaced from an anchoring region of the flaredsection to promote tissue ingrowth with the flared section. In someembodiments, the liner is spaced apart from a medial anchoring region ofthe medial section to promote tissue ingrowth with the medial section.In some embodiments, the medial anchoring region is provided at anexpanded portion of the medial section, and wherein the expanded portionhas a third diameter greater than the diameter of the medial section. Insome embodiments, the liner is spaced from the expanded portion topromote tissue ingrowth with the expanded portion. In some embodiments,the anchoring region is located along a sloped portion of the flaredsection, and wherein the sloped portion extends away from a centrallongitudinal axis extending through the lumen. In some embodiments, themedial section has a substantially uniform diameter. In someembodiments, the flared section has a first scaffold configuration,wherein the medial section has a second scaffold configuration, andwherein the first and second scaffold configurations are different.

In one or more embodiments, a system may include a stent comprising atubular scaffold having a first end opposite a second end, wherein alumen extends between the first and second ends. The tubular scaffoldmay include a flared section and a medial section extending from theflared section, wherein a first diameter of the flared section isgreater than a second diameter of the medial section. The stent mayfurther include a liner extending partially along a surface of thetubular scaffold, wherein the liner is spaced from an anchoring regionof the flared section to promote tissue ingrowth with the flaredsection. The system may further include a sheath extending from thesecond end of the tubular scaffold, the sheath having a proximal endopposite a distal end, wherein a lumen extends between the proximal anddistal ends. In some embodiments, the system may include a second stentcoupled to the distal end of the sheath. In some embodiments, the secondstent may include a second tubular scaffold and a second liner extendingpartially along a surface of the second tubular scaffold. In someembodiments, the second tubular scaffold may include a second flaredsection, and a second medial section extending from the second flaredsection, wherein a first diameter of the second flared section isgreater than a second diameter of the second medial section, and whereinthe second liner is spaced from a second anchoring region of the secondflared section to promote tissue ingrowth with the second flaredsection. In some embodiments, the liner is spaced apart from a medialanchoring region of the medial section to promote tissue ingrowth withthe medial section. In some embodiments, the anchoring region is locatedalong a sloped portion of the flared section, and wherein the slopedportion extends away from a central longitudinal axis extending throughthe lumen. In some embodiments, the medial section includes an expandedportion, the expanded portion having a third diameter greater than thediameter of the medial section. In some embodiments, the liner is spacedfrom the expanded portion to promote tissue ingrowth with the expandedportion. In some embodiments, the sheath comprises a structural supportelement.

In one or more embodiments, a method may include deploying a systemwithin a gastrointestinal (GI) tract of a patient, the system includinga stent having a tubular scaffold having a first end opposite a secondend, wherein a lumen extends between the first and second ends. Thetubular scaffold may include a flared section and a medial sectionextending from the flared section, wherein a diameter of the flaredsection is greater than a diameter of the medial section; and. The stentmay further include a liner extending partially along a surface of thetubular scaffold, wherein the liner is spaced from an anchoring regionof the flared section, and wherein the anchoring region is exposed tothe GI tract to promote tissue ingrowth between the anchoring region andthe GI tract. The method may further include positioning the flaredsection along one side of a GI tract target site, and positioning themedial section directly adjacent the GI tract target site. In someembodiments, the method may further include determining a location ofthe GI tract target site, wherein the GI tract target site correspondsto a leak of the GI tract. In some embodiments, the method may furtherinclude bypassing a portion of the GI tract using a sheath extendingfrom the second end of the tubular scaffold, the sheath having aproximal end opposite a distal end, wherein a lumen extends between theproximal and distal ends. In some embodiments, the method may includesecuring a second stent within the GI tract, the second stent coupled tothe distal end of the sheath.

Various one or more of the features summarized above may beinterchanged, exchanged, combined or substituted with or for otherfeatures summarized above, for use in connection with the medicalsystems and methods summarized above, and with respect to theembodiments described in greater detail below and embodiments otherwisewithin the scope of the present disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting embodiments of the present disclosure are described by wayof example with reference to the accompanying figures, which are notintended to be drawn to scale. In the figures, each identical or nearlyidentical component illustrated is typically represented by a singlenumeral. For purposes of clarity, not every component is labeled inevery figure, nor is every component of each embodiment shown whereillustration is not necessary to allow those of ordinary skill in theart to understand the disclosure. Furthermore, some of the figuresinclude cross-sectional views in the form of “slices”, or “near-sighted”cross-sectional views, omitting certain background lines or featuresotherwise visible in a “true” cross-sectional view, for illustrativeclarity. In the figures:

FIGS. 1A-1C are side views of stents according to embodiments of thepresent disclosure;

FIG. 2 depicts a stent within a GI tract of a patient according toembodiments of the present disclosure;

FIG. 3 is a side view of a stent according to embodiments of the presentdisclosure;

FIGS. 4A-4E are side views of stents with various expanded portionsaccording to embodiments of the present disclosure;

FIG. 5A is a side view of a stent including a liner having a recessedsection according to embodiments of the present disclosure;

FIG. 5B is a cross-sectional view of the stent and a liner of FIG. 5Aaccording to embodiments of the present disclosure;

FIG. 6A is a side view of a stent including a liner having a recessedsection according to embodiments of the present disclosure;

FIG. 6B is a cross-sectional view of a stent and liner similar to thatof FIG. 6A and according to embodiments of the present disclosure;

FIG. 6C is a side view of a stent including a liner having a recessedsection according to embodiments of the present disclosure;

FIG. 7 is a perspective view of a system according to embodiments of thepresent disclosure;

FIG. 8A demonstrates the system of FIG. 7 placed within a GI tractduring a restrictive bariatric treatment according to embodiments of thepresent disclosure;

FIG. 8B demonstrates the system of FIG. 7 placed within a GI tract fortreatment of leaks according to embodiments of the present disclosure;

FIG. 9A demonstrates a system placed within a GI tract during arestrictive bariatric treatment according to embodiments of the presentdisclosure;

FIG. 9B demonstrates a system placed within a GI tract for treatment ofleaks according to embodiments of the present disclosure;

FIG. 10 demonstrates a system placed within a GI tract for treatment ofleaks according to embodiments of the present disclosure;

FIG. 11 is a side perspective view of a sheath according to embodimentsof the present disclosure;

FIG. 12 is a side perspective view of a sheath according to embodimentsof the present disclosure;

FIG. 13 is a side perspective view of a system according to embodimentsof the present disclosure;

FIG. 14A is a side perspective view of a stent according to embodimentsof the present disclosure;

FIG. 14B is a side cross-sectional view of the stent of FIG. 14Aaccording to an embodiment of the present disclosure;

FIG. 14C is a side cross-sectional view of the stent of FIG. 14Aaccording to an embodiment of the present disclosure;

FIG. 15A is a side view of a system according to embodiments of thepresent disclosure;

FIG. 15B demonstrates the system of FIG. 15A within a GI tract accordingto embodiments of the present disclosure; and

FIG. 16 is a flow diagram of a method according to embodiments of thepresent disclosure.

DETAILED DESCRIPTION

The present disclosure is not limited to the particular embodimentsdescribed herein. The terminology used herein is for the purpose ofdescribing particular embodiments only, and is not intended to belimiting beyond the scope of the appended claims. Unless otherwisedefined, all technical terms used herein have the same meaning ascommonly understood by one of ordinary skill in the art to which thedisclosure belongs.

As described above, self-expanding metal stents (SEMS) are usedextensively in a minimally invasive manner throughout thegastrointestinal (GI) tract for the treatment of a myriad of diseasestates including, but not limited to, vessel lumen closure (e.g.,stricture due to tumorous growth, surgical etiologies, etc.) and GIbypass complications (e.g., post bariatric leaks treatments). SEMS maybe removable or permanent, dependent on the disease state undertreatment, with removability typically defined by the presence orabsence of a durable coating. Permanent SEMS may not have a coating,which when placed within the GI tract, allows for vessel tissue ingrowthdue to stimulated hyperplasia of the vessel. Eventually the SEMS isembedded in place as a result of the tissue ingrowth.

As further described herein, embodiments of the present disclosureprovide stents, systems, and methods for treatment of GI tract diseasesfor a consistent, repeatable approach for anti-migration to treat themyriad of underlying conditions. In some embodiments, a stent mayinclude a tubular scaffold having a first end opposite a second end,wherein a lumen extends between the first and second ends. The tubularscaffold may include a flared section and a medial section extendingfrom the flared section, wherein a diameter of the flared section isgreater than a diameter of the medial section. The stent may furtherinclude a liner extending partially along a surface of the tubularscaffold, wherein the liner is spaced from an anchoring region of theflared section to promote tissue ingrowth with the flared section.

Turning now to FIG. 1A, a stent 100 according to embodiments of thedisclosure will be described in greater detail. As shown, the stent 100may include a tubular scaffold (hereinafter “scaffold”) 102 having afirst end 104 opposite a second end 106. The scaffold 102 may define alumen 105 extending between the first end 104 and second end 106, forexample, along a central longitudinal axis 108. When positioned in abody lumen, such as a patient’s GI tract, the first end 104 (in thiscase, the proximal end) may be positioned closest to a patient’s mouth.

Additionally, the stent 100 may include one or more strut members 109forming the tubular scaffold 102. The strut members 109 may extendhelically, longitudinally, circumferentially, or otherwise along stent100. While FIG. 1A shows the strut members 109 generally extending alongan entire length of the stent 100, the strut members 109 may extend onlyalong a portion of the stent 100 in other embodiments.

As further shown, the scaffold 102 may include a flanged or flaredsection 110 connected to, or integrally formed with, a medial section112. In some embodiments, a first diameter ‘D1’ of the flared section110 may be greater than a second diameter ‘D2’ of the medial section112. As shown, the medial section 112 may have a generally uniformdiameter along its length. The flared section 110 may include a slopedportion 114 extending away from the central longitudinal axis 108. Insome embodiments, the sloped portion 114 is at an intersection betweenthe flared section 110 and the medial section 112.

In some embodiments, the stent 100 may be balloon or self-expanding.Self-expanding stent examples may include stents having one or morestrut members 109 combined to form a rigid and/or semi-rigid stentstructure. For example, the strut members 109 may be one or more wiresor filaments which are braided, wrapped, intertwined, interwoven,weaved, knitted, looped (e.g., bobbinet-style), or the like to form thescaffold 102. Alternatively, the stent 100 may be a monolithic structureformed from a cylindrical tubular member, such as a single, cylindricaltubular laser-cut Nitinol tubular member, in which the remainingportions of the tubular member form the strut members 109. Openings orinterstices through a wall of the stent 100 may be defined betweenadjacent the strut members 109.

The stent 100 may be constructed from a variety of non-limitingmaterials. For example, when balloon or self-expandable, the stent 100may be constructed from a metal (e.g., Nitinol, Elgiloy, stainlesssteel, cobalt-chrome, positive temperature co-efficient of resistivity,etc.). In other examples, the stent 100 may be constructed from apolymeric material (e.g., polyethylene terephthalate, poly(methylmethacrylate)). In yet other examples, the stent 100 may be constructedfrom a combination of metallic and polymeric materials. In still yetother examples, the stent 100 may include a bioabsorbable and/orbiodegradable material (e.g., a poly(lactic-co-glycolic acid) polymer).

As shown in FIG. 1B, the stent 100 may include a liner 120 extendingbetween the first end 104 and the second end 106. The liner 120 may beprovided to maintain a passageway through the stent 100, as well as toprevent tissue ingrowth along the scaffold 102 in certain areas. In thenon-limiting embodiment shown, the liner 120 may be formed over anexterior surface 122 of the scaffold 102. However, the liner 120 may beformed only partially along the exterior of the scaffold 102, as will bedescribed in greater detail herein. In other embodiments, the liner 120may be formed along an interior surface 124 of the scaffold 102. In yetother embodiments, the liner 120 may be formed along both the exteriorsurface and the interior surface 124 of the scaffold.

In various embodiments, the liner 120 may be a polymeric material, suchas silicone, polyurethane, polyvinylidene difluoride (PVDF),Chronoflex®, or similar biocompatible polymeric formulations. In yetother embodiments, the liner 120 may include a ciliated coating (notshown) along an interior surface thereof. As shown, the liner 120 mayextend between strut members 109, thereby filling any space betweenadjacent strut members 109 of the scaffold 102. Reference to a liner maybe understood as a coating, where a portion of the coating is coupled toat least a portion of a stent, and a portion of the coating may befloating with respect to the stent.

In some embodiments, the liner 120 is spaced from an anchoring region125 of the flared section 110 to promote tissue ingrowth between the GItract and the anchoring region 125 of the flared section 110. Forexample, the liner 120 at the anchoring region 125 may extend radiallyinward towards the central longitudinal axis 108 such that the liner 120is generally not in contact with the interior surface 124 of thescaffold 102. As a result, the anchoring region 125 may promote or allowtissue ingrowth to anchor the flared section 110 in place within the GItract.

In some embodiments, the liner 120 may include an elastic materialcomponent configured to stretch radially inward, for example, as tissuegrows through the interstices of the scaffold 102 in the anchoringregion 125. The liner 120 may deflect, stretch, etc. radially inward inresponse to inward forces (e.g., tissue ingrowth) acting thereupon.

In other embodiments, it may be desirable to limit the amount of inwarddeflection of the liner 120. For example, the liner 120 may define alumen extending therein, wherein the lumen is designed to permit foodand/or or other digestible material to flow therethrough. Therefore, insome instances it may be desirable to design the liner 120 to preservethe passageway defined by the lumen 105. In other words, it may bedesirable in some instances to prevent or minimize an amount the liner120 closes radially. In some instances, the liner 120 may includereinforcing filaments (e.g., fibers) embedded in the material of theliner 120 that may be drawn taut after a threshold amount of stretchingof the material of the liner 120 to prevent further stretching of theliner 120. In some instances, the reinforcement filaments may bearranged longitudinally, circumferentially, helically, randomly, orotherwise.

Examples of liners and stent/liner configurations may include, but arenot limited to, those shown and described in U.S. Pat. ApplicationPublication No. US2018/0250118, filed Mar. 1, 2018, and titled“Esophageal Stent Including an Inner Liner,” and U.S. Pat. ApplicationPublication No. US2018/0280167, filed Mar. 27, 2018, and titled“Retrievable Stent System,” both of which applications are incorporatedby reference herein in their entireties and for all purposes.

As demonstrated in FIG. 1C, the scaffold 102 may include multiplesections joined together. For example, the medial section 112 mayinclude a first component 128 coupled to a second component 130. Thefirst and second components 128, 130 may be joined together using anyvariety of attachment means. In the non-limiting embodiment shown, thestrut members 109 of the first component 128 may be arranged in a firstconfiguration, e.g., knitted, while the strut members 109 of the secondcomponent 130 may be arranged in a second configuration, e.g., braided.In some embodiments, the first component 128 and the second component130 may have the same or different weave patterns. Embodiments hereinare not limited in this context.

FIG. 2 illustrates the use of the stent 100 within a GI tract 132 of apatient according to embodiments of the present disclosure. In thisnon-limiting example, the GI tract 132 may include a staple line 131 asa result of a sleeve gastrectomy procedure, for example. As shown, thestent 100 may be deployed to a GI tract target site 134, which maycorrespond to a leak, perforation, or tear along the staple line 131. Asshown, the flared section 110 may be positioned within a proximalsection of the GI tract 132, in this instance the patient’s esophagus,while the medial section 112 may extend down further into the GI tract132, in this instance a stomach remnant. The anchoring region 125 of theflared section 110 may be provided adjacent the GI tract 132 to promotetissue ingrowth between the GI tract 132 and the flared section 110.Meanwhile, the liner 120 along the medial section 112 may be positioneddirectly adjacent the GI tract target site 134 to prevent or minimizethe leak.

FIG. 3 demonstrates a stent 300 according to embodiments of thedisclosure. The stent 300 may be the same or similar in many aspects tothe stent 100 described above. As such, only certain aspects of thestent 300 may be described hereinafter for the sake of brevity.

As shown, the stent 300 may include a scaffold 302 having a first end304 opposite a second end 306. The scaffold 302 may define a lumen 305extending between the first end 304 and second end 306, for example,along a central longitudinal axis 308. The scaffold 302 may include aflared section 310 connected to, or integrally formed with, a medialsection 312. The flared section 310 may include a sloped portion 314extending away from the central longitudinal axis 308. In someembodiments, the sloped portion 314 joins the flared section 310 to themedial section 312.

As shown, the medial section 312 may include a medial anchoring region335, which is a bare section of the scaffold 302 for promoting tissueingrowth between the medial section 312 and a GI tract. As shown, aliner 320 extending along the scaffold 302 may be spaced from the medialanchoring region 335 to promote tissue ingrowth. In some embodiments,the liner 320 at the medial anchoring region 335 may extend radiallyinward towards the central longitudinal axis 308. The liner 320 may alsobe spaced from an anchoring region 325 of the flared section 310 topromote tissue ingrowth between the GI tract and the flared section 310.In some embodiments, the anchoring region 325 is located along thesloped portion 314. Once inserted within a patient, the anchoring region325 of the flared section 310 may be positioned along one side of (e.g.,above) a GI tract target site (not shown), while the medial anchoringregion 335 of the medial section 312 may be positioned adjacent and/orbelow the GI tract target site to isolate a leak at the GI tract targetsite.

FIG. 4A demonstrates a stent 400 according to embodiments of the presentdisclosure. The stent 400 may be the same or similar in many aspects tothe stents 100 and/or 200 described above. As such, only certain aspectsof the stent 400 may be described hereinafter for the sake of brevity.

As shown, the stent 400 may include a scaffold 402 having a first end404 opposite a second end 406. The scaffold 402 may define a lumen 405extending between the first end 404 and second end 406, for example,along a central longitudinal axis 408. A liner 420 may be provided alongthe scaffold 402. The scaffold 402 may include a flared section 410connected to, or integrally formed with, a medial section 412. In someembodiments, a first diameter ‘D1’ of the flared section 410 may begreater than a second diameter ‘D2’ of the medial section 412. Theflared section 410 may include a sloped portion 414 extending away fromthe central longitudinal axis 408. In some embodiments, the slopedportion 414 joins the flared section 410 to the medial section 412.

As shown, the medial section 412 may include a medial anchoring region435, which may be a bare spot / region along the scaffold 402 to promotetissue ingrowth between the medial section 412 and a GI tract. In someembodiments, the medial anchoring region 435 may be provided at anexpanded portion 440 of the medial section 412. As shown, the expandedportion 440 may have a third diameter ‘D3’, which is greater than D2 ofthe medial section 412. The expanded portion 440 may have a curvature,e.g., expanding radially outward from the medial section 412, such thatthe third diameter D3 is the maximum diameter of the curvature. In someembodiments, D3 may also be greater than D1 of the flared section 410.In other embodiments, D3 is equal to or less than D1. Embodiments hereinare not limited in this context.

As further shown, the liner 420 extending along the scaffold 402 may bespaced from the expanded portion 440 to promote tissue ingrowth alongcertain portions of the medial section 412, such as at the medialanchoring region 435. In some embodiments, the liner 420 locatedradially inward from the expanded portion 440 may curve or extendtowards the central longitudinal axis 408. In other embodiments, theliner 420 may be generally straight at the expanded portion 440, asshown. Once inserted within a patient, an anchoring region 425 of theflared section 410 may be positioned along one side of (e.g., above) aGI tract target site (not shown), while the expanded portion 440 of themedial section 412 may be positioned at or below the GI tract targetsite. The anchoring region 425 may secure the flared section 410 withinthe GI tract, while the expanded portion 440 may interact with the GItract target site to promote a hyperplastic response from the tissue ofthe GI tract. In some embodiments, a distal portion 442 of the medialsection 412 may extend from the expanded portion 440, acting as aconduit to bypass the GI tract target site.

It will be appreciated that the expanded portion 440 may take on avariety of different configurations. For example, the expanded portion440 of FIG. 4A may have a generally spherical shape cross-section, anexpanded portion 440B of FIG. 4B may have a generally trapezoidal shapecross-section, an expanded portion 440C of FIG. 4C may have a generallypentagonal shape cross-section, and an expanded portion 440D of FIG. 4Dmay have a generally chordal shape cross-section. Embodiments herein arenot limited in this context.

Furthermore, it will be appreciated that a length of the variousexpanded portion(s) 440A-440E may be modified to influence an amount ofinteraction between the medial anchoring region 435 and the GI tract.For example, as shown in FIG. 4E, a length ‘L1’ of the expanded portion440E may be increased relative to an overall length ‘L2’ of the medialsection 412. As will be appreciated, tissue ingrowth of the GI tractgenerally increases as the length L1 increases.

Turning now to FIGS. 5A-5B, a liner 520 of a stent 500 according toembodiments of the present disclosure will be described in greaterdetail. As shown, the liner 520 may have a non-circular cross-section topromote tissue ingrowth between a scaffold 502 of the stent 500 and a GItract. In this embodiment, the liner 520 may include a recessed section550 spaced from an interior surface 524 of the scaffold 502. Therecessed section 550 may provide a medial anchoring region 535 of thescaffold 502. In some embodiments, the medial anchoring region 535 maybe provided at an expanded portion 540 of the medial section 512. Inother embodiments, the medial section 512 may have a substantiallyconstant diameter along its length.

In FIGS. 6A-6B, a liner 620 of a stent 600 may include a plurality ofrecessed sections 650 spaced from an interior surface 624 of a scaffold602 of the stent 600. The recessed sections 650, which may be spacedapart circumferentially along the liner 620 (different configurationsbeing shown in FIG. 6A and FIG. 6B as non-limiting examples), mayprovide a plurality of medial anchoring regions 635 along the scaffold602 to promote tissue ingrowth between the scaffold 602 and the medialsection 612. In some embodiments, the medial anchoring region 635 may beprovided at an expanded portion 640 of the medial section 612. In otherembodiments, the medial section 612 may have a substantially constantdiameter along its length.

In yet other embodiments, as shown in FIG. 6C, the expanded portion 640of the medial section 612 may not include the liner 620. Instead, theexpanded portion 640 remains exposed to promote hyperplasia tissuegrowth 627 between a body lumen (not shown) and the exposed portion ofthe scaffold 602. The hyperplasia tissue growth 627 may act as a seal toform a continuous channel through an interior of the scaffold 602.

Turning now to FIG. 7 , a system 701 according to embodiments of thepresent disclosure will be described in greater detail. As shown, thesystem 701 may include a stent 700 having a tubular scaffold(hereinafter “scaffold”) 702. The stent 700 may be the same or similarin many aspects to the stents 100, 300, 400, 500, and 600 describedabove. As such, only certain aspects of the stent 700 may be describedhereinafter for the sake of brevity.

As shown, the stent 700 may include a first flared section 710 at afirst end 704, and a second flared section 711 at a second end 706.Between the first flared section 710 and the second flared section 711lies a medial section 712. As shown, the medial section 712 may have areduced diameter as compared to the diameters of the first and secondflared sections 710, 711. As further shown, the stent 700 may include aliner 720 disposed along a surface of the scaffold 702.

In some embodiments, a sheath 760 may be coupled to the second end 706of the stent 700. The sheath 760 may be a flexible tube having aproximal end 762 and a distal end 764, the sheath 760 defining a lumenextending between the proximal and distal ends 762, 764. Althoughnon-limiting, the sheath 760 may be Silicone, UE, PTFE, ePTFE,Chronoflex, PMMA, PVDF, and the like.

As further shown, the system 701 may include a second stent 765 coupledto the distal end 764 of the sheath 760. In some embodiments, the secondstent 765 may include a second tubular scaffold (hereinafter “secondscaffold”) 768 defined by a plurality of stent members 769 arranged intoany variety of configurations. The second scaffold 768 of the stent 765may have a constant diameter or a varied diameter. For example, in thecase of the latter, the second scaffold 768 may include a first flaredsection 770 connected to, or integrally formed with, a second medialsection 772. In some embodiments, the second tubular scaffold 768 mayinclude a second flared section 773 extending from an opposite side ofthe second medial section 772. In some embodiments, a diameter of thefirst and second flared sections 770, 773 of the second scaffold 768 isgreater than a diameter of the second medial section 772. Embodimentsherein are not limited in this context.

Although not shown, a second liner may extend along a surface (e.g.,inner and/or outer) of the second scaffold 768. In some embodiments, thesecond liner may be spaced from the second scaffold 768 in one or moresecond anchoring regions to promote tissue ingrowth between the secondscaffold 768 and a GI tract of a patient. In other embodiments, no lineris present along the second scaffold 768.

FIGS. 8A-8B demonstrates an example use of the system 701 within a GItract 732 of a patient according to embodiments of the presentdisclosure. Although non-limiting, FIG. 8A demonstrates the system 701placed within the GI tract 732 for a restrictive bariatric treatment. Asshown, the sheath 760 may bypass a portion of the GI tract 732. FIG. 8Bdemonstrates the system 701 used for treatment of gastrocutaneousfistulas. As shown, the stent 700 may be positioned within a proximalsection of the GI tract 732, while the sheath 760 extends down furtherinto the GI tract 732. An anchoring region 725 of the flared section 710is provided directly adjacent an interior of the GI tract 732 to promotetissue ingrowth between the GI tract 732 and the flared section 710.

The second stent 765, which is coupled to the sheath 760, may also bepositioned within the GI tract 732, for example, below a pyloric region780 thereof. In some embodiments, the second stent 765 may include oneor more second anchoring regions (not shown) to promote tissue growthbetween the GI tract 732 and the second scaffold 768.

In some embodiments, the system 701 may not include a second stentconnected to the sheath 760. For example, as shown in FIGS. 9A-9B, thestent 700 may be positioned within a proximal section of the GI tract732, while the sheath 760 may extend down further into the GI tract 732.In some embodiments, the sheath 760 may extend beyond the pyloric region780 of the GI tract 732. Although non-limiting, FIG. 9A demonstrates thesystem 701 placed within the GI tract 732 for a restrictive bariatrictreatment, while FIG. 9B demonstrates the system 701 used for thetreatment of leaks, for example, intestinal fistula, extraintestinalfistula, gastrocutaneous fistula, complex fistula, etc. As shown in FIG.9A, the sheath 760 may extend even further along the GI tract 732, forexample, into a duodenum 782 (also known as gastrojejunal bypass (GJbypass)).

Turning now to FIG. 10 , the system 701 in use within a patientaccording to another embodiment of the present disclosure will bedescribed. Although non-limiting, the system 701 may be particularlyeffective during a restrictive bariatric treatment using, for example, agastro-jejunum bypass. As shown, the stent 700 may be positioned withina proximal section of the GI tract 732, while the sheath 760 may extendthrough a stomach 781 of the patient. The second stent 765, which iscoupled to the sheath 760, may also be positioned within the GI tract732, for example, between both the stomach 781 and a duodenum 782extending from the stomach 781. As shown, the second scaffold 768 of thesecond stent 765 may be positioned such that the first flared section770 is located within the stomach 781, while the second flared section773 is located within the duodenum 782. The second medial section 772may extend between the first flared section 770 and the second flaredsection 773, creating a bypass between the stomach 781 and the duodenum782. Although not shown in FIG. 10 , the second liner 775 may extendthrough the second medial section 772. Furthermore, one or moreanchoring regions may be located along the first flared section 770, thesecond flared section 773, and/or the second medial section 772 tosecure the second stent 765 in place between the stomach 781 and theduodenum 782.

In FIG. 11 , a sheath 1160 according to embodiments of the presentdisclosure is shown. The sheath 1160 may include a structural supportelement 1183 extending along a length of the sheath 1160, for example,between a proximal end 1162 and a distal end 1164. In some embodiments,the structural support element 1183 may be a spiral or helical ribextending along the sheath 1160. The structural support element 1183 maybe disposed along an inner and/or outer surface of the sheath 1160, ormay be embedded within the sheath 1160, for example, between one or morelayers thereof. The structural support element 1183 may provide rigidityto the sheath 1160. In non-limiting embodiments, the structural supportelement 1183 may be made from enhanced, thickened or tubular hollow,tubular solid strips of the native polymer or denser polymer.Additionally, or alternatively, the structural support element mayinclude sections of a more rigid material, e.g., nitinol, stainlesssteel, etc.

In FIG. 12 , a sheath 1260 according embodiments of the presentdisclosure is shown. The sheath 1260 may include a flexible section 1284disposed between a proximal end 1262 and a distal end 1264. In someembodiments, the flexible section 1284 includes a length of corrugatedmaterial arranged as a series of ridges 1285 and furrows 1286. Theflexible section 1284 may provide flexibility to the sheath 1260. Insome embodiments, the flexible section 1284 may include one or morestructural support members. In non-limiting embodiments, the series ofridges 1285 and furrows 1286 of the corrugated material may correspondto a plurality of ripples formed in the sheath 1260. The series ofridges 1285 and furrows 1286 may also be formed by placing strips ofalternating density or alternating thickness next to one another.Alternatively, or additionally, the series of ridges 1285 and furrows1286 may be formed by placing strips of alternate polymer layers withdiffering elasticity strips adjacent to each other. Alternatively, oradditionally, the series of ridges 1285 and furrows 1286 may be formedby an embedded rib(s) manufactured from materials such as Nitinol,stainless steel, etc.

Turning now to FIG. 13 , a system 1301 according to embodiments of thepresent disclosure will be described. The system 1301 may be the same orsimilar in many aspects to the system 701 described above. As such, onlycertain aspects of the system 1301 may be described hereinafter for thesake of brevity.

As shown, the system 1301 may include a first stent 1300 and a secondstent 1365 coupled together by a first sheath 1360. For example, a firstend 1362 of the first sheath 1360 may be coupled to the first stent1300, while a second end 1364 of the first sheath 1360 may be coupled tothe second stent 1365. In some embodiments, the first sheath 1360 may bea flexible conduit defining a lumen. Although non-limiting, the firstsheath 1360 may include one or more structural support elements and/orflexible sections.

The system 1301 may further include a second sheath 1388 extending fromthe second stent 1365. The second sheath 1388 may include a proximal end1389 coupled the second stent 1365, and a distal end 1390 extendingfarther within a GI tract of a patient. The second sheath 1388 may bethe same or similar to the first sheath 1360. In other embodiments, thesecond sheath 1388 may be different than the first sheath 1360, forexample, depending on a location of use within a GI tract of thepatient. Although not shown, it will be appreciated that an additionalstent may be connected to the second sheath 1388, for example, at thedistal end 1390 thereof.

As shown, the first stent 1300 may include a first flared section 1310at a first end 1304, and a second flared section 1311 at a second end1306. Between the first flared section 1310 and the second flaredsection 1311 lies a medial section 1312. As shown, the medial section1312 may have a reduced diameter as compared to the diameters of thefirst and second flared sections 1310, 1311. The first sheath 1360 mayextend from, and connect with, the second end 1306 of the first stent1300.

In some embodiments, the first stent 1300 may include a liner 1320disposed along a surface of a scaffold 1302. The liner 1320 may bespaced from an anchoring region 1325 along the scaffold 1302 to promotetissue ingrowth with the GI tract. Although non-limiting, the anchoringregion 1325 may be disposed along the first flared section 1310, thesecond flared section 1311, and/or the medial section 1322.

As further shown, the second stent 1365 may be the same or similar tothe first stent 1300 in some embodiments. For example, a second scaffold1368 of the second stent 1365 may include a first flared section 1370and a second flared section 1373 connected by a second medial section1372. In some embodiments, a second liner 1375 may extend along asurface (e.g., inner and/or outer) of the second scaffold 1368. Thesecond liner 1375 may be spaced from the second scaffold 1368 in one ormore second anchoring regions 1379 to promote tissue ingrowth betweenthe second scaffold 1368 and the GI tract. Although non-limiting, thesecond anchoring regions 1379 may be disposed along the first flaredsection 1370, the second flared section 1373, and/or the second medialsection 1372.

Turning now to FIGS. 14A-14C, a stent 1400 according to embodiments ofthe present disclosure will be described in greater detail. As shown, ascaffold 1402 of the stent 1400 may have a first end 1404 opposite asecond end 1406, wherein the scaffold 1402 defines a lumen extendingbetween the first end 1404 and second end 1406, for example, along acentral longitudinal axis 1408.

The stent 1400 may include one or more strut members 1409 (FIG. 14A)forming the tubular scaffold 1402. The strut members 1409 may extendalong the stent helically, longitudinally, circumferentially, orotherwise. As further shown, the scaffold 1402 may include a firstflared/flanged section 1410 and a second flared/flanged section 1411connected to, or integrally formed with, a medial section 1412. In someembodiments, a diameter of the first and/or second flared sections 1410,1411 may be greater than a diameter of the medial section 1412. Asshown, the medial section 1412 may generally have a uniform diameteralong its length.

In some embodiments, the stent 1400 may be balloon or self-expanding.Self-expanding stent examples may include stents having one or morestrut members 1409 combined to form a rigid and/or semi-rigid stentstructure. For example, the strut members 1409 may be wires or filamentswhich are braided, wrapped, intertwined, interwoven, weaved, knitted,looped (e.g., bobbinet-style), or the like to form the stent structure.Alternatively, the stent 1400 may be a monolithic structure formed froma cylindrical tubular member, such as a single, cylindrical tubularlaser-cut Nitinol tubular member, in which the remaining portions of thetubular member form the strut members 1409. Openings or intersticesthrough the wall of the stent 1400 may be defined between adjacent strutmembers 1409.

The stent 1400 in examples disclosed herein may be constructed from avariety of materials. For example, when balloon or self-expandable, thestent 1400 may be constructed from a metal (e.g., Nitinol, Elgiloy,etc.). In other examples, the stent 1400 may be constructed from apolymeric material (e.g., PET). In yet other examples, the stent 1400may be constructed from a combination of metallic and polymericmaterials. In still yet other examples, the stent 1400 may include abioabsorbable and/or biodegradable material.

As further shown, the stent 1400 may include a liner 1420 extendingpartially along the scaffold 1402. In the non-limiting embodiment shown,the liner 1420 may be formed along an interior surface 1424 of thescaffold 1402. In other embodiments, the liner 1420 may be formed alongan exterior surface 1422 of the scaffold 1402. In yet other embodiments,the liner 1420 may be formed along both the exterior surface 1422 andthe interior surface 1424 of the scaffold 1402.

Furthermore, the liner 1420 may include one or more layers joinedtogether, wherein the liner 1420 is provided along the scaffold 1402 toprevent or minimize tissue ingrowth. In some embodiments, the liner 1420may be an elastomeric or non-elastomeric material. As shown, the liner1420 may extend between strut members 1409, thereby filling any spacebetween adjacent strut members 1409 of the scaffold 1402.

In some embodiments, the liner 1420 is connected to the scaffold 1402along the first flared/flanged section 1410 and the secondflared/flanged section 1411, and spaced from an anchoring region 1425 ofthe medial section 1412 to promote tissue ingrowth between a GI tractand the scaffold 1402 of the medial section 1412. For example, the liner1420 at the anchoring region 1425 may extend radially inward towards thecentral longitudinal axis 1408 such that the liner 1420 is generally notin contact with the interior surface 1424 of the scaffold 1402 along themedial section 1412. As shown in FIG. 14B, the anchoring region 1425 maygenerally extend along an entire length of the medial section 1412. Asshown in FIG. 14C, the anchoring region 1425 may extend along only aportion of the medial section 1412. It will be appreciated that the sizeof the anchoring region 1425 may be selected to increase or decrease anamount of tissue ingrowth between the medial section 1412 and the GItract. Embodiments herein are not limited in this context.

Turning now to FIGS. 15A-15B, a system 1501 according to embodiments ofthe present disclosure will be described. As shown, the system 1501 mayinclude a stent 1500 coupled to a sheath 1560. The stent 1500 may be thesame or substantially the same as the stent 1400 described above. Asshown in FIG. 15B, the stent 1500 may be used to connect a stomach 1581and a duodenum 1582 of a patient, with the sheath 1560 extending fartherinto the duodenum 1582. More specifically, a scaffold 1502 of the stent1500 may be positioned such that a first flared section 1510 is locatedwithin the stomach 1581, while a second flared section 1511 is locatedwithin the duodenum 1582. A medial section 1512 may extend between thefirst flared section 1510 and the second flared section 1511, creating abypass between the stomach 1581 and the duodenum 1582.

A liner 1520 (FIG. 15A) may extend through the medial section 1512. Theliner 1520 may be spaced from an interior surface 1522 of the scaffold1502 to create one or more anchoring regions 1525 along the medialsection 1512. The anchoring regions 1525 may promote tissue growth tosecure the stent 1500 in place between the stomach 1581 and the duodenum1582, for example, across a pyloric valve 1587 as demonstrated in FIG.15B.

In some embodiments, the sheath 1560 may be a length of corrugatedmaterial extending through the duodenum 1582. The corrugated materialmay be defined by a series of ridges 1585 and furrows 1586, wherein thecorrugated material may provide flexibility to the sheath 1560 fortraversing the duodenum 1582. In some embodiments, the corrugatedmaterial may also act as a liner to inhibit nutritional uptake, forexample, to treat diabetes and and/or promote weight loss.

FIG. 16 is a flow diagram of a method 1600 according to embodiments ofthe present disclosure. At block 1601, the method 1600 may includedetermining a location of the GI tract target site, wherein the GI tracttarget site corresponds to a defect of the GI tract.

At block 1603, the method 1600 may include deploying a system within theGI tract of a patient, wherein the system includes a stent having atubular scaffold including a flared section, and a medial sectionextending from the flared section, wherein the tubular scaffold mayfurther include a liner extending partially along a surface of thetubular scaffold, wherein the liner is spaced from an anchoring regionof the flared section, and wherein the anchoring region is exposed tothe GI tract to promote tissue ingrowth between the anchoring region andthe GI tract.

At block 1605, the method 1600 may include positioning the flaredsection along one side of a GI tract target site, and positioning themedial section directly adjacent the GI tract target site. In someembodiments, mucosal abrasion of the insertion site within the GI tractis used to promote tissue ingrowth between one or more regions orsections of the stent, such as the anchoring regions, and the GI tract,such as to mitigate migration of the stent from the target site. In someembodiments, the method 1600 may further include bypassing a portion ofthe GI tract using a sheath extending from the second end of the tubularscaffold, the sheath having a proximal end opposite a distal end,wherein a lumen extends between the proximal and distal ends. In someembodiments, the method 1600 may further include securing a second stentwithin the GI tract, the second stent coupled to the distal end of thesheath. In some embodiments, mucosal abrasion of the insertion sitewithin the GI tract is used to promote tissue ingrowth between one ormore regions or sections of the second stent, such as the anchoringregions, and the GI tract, such as to mitigate migration of the secondstent from the target site.

The stents described herein may be made from a metal, metal alloy,polymer (some examples of which are disclosed below), a metal-polymercomposite, ceramics, combinations thereof, and the like, or othersuitable material. Some examples of suitable polymers may includepolytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE),fluorinated ethylene propylene (FEP), polyoxymethylene (POM, forexample, DELRIN® available from DuPont), polyether block ester,polyurethane (for example, Polyurethane 85A), polypropylene (PP),polyvinylchloride (PVC), polyether-ester (for example, ARNITEL®available from DSM Engineering Plastics), ether or ester basedcopolymers (for example, butylene/poly(alkylene ether) phthalate and/orother polyester elastomers such as HYTREL® available from DuPont),polyamide (for example, DURETHAN® available from Bayer or CRISTAMID®available from Elf Atochem), elastomeric polyamides, blockpolyamide/ethers, polyether block amide (PEBA, for example availableunder the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA),silicones, polyethylene (PE), Marlex high-density polyethylene, Marlexlow-density polyethylene, linear low density polyethylene (for exampleREXELL®), polyester, polybutylene terephthalate (PBT), polyethyleneterephthalate (PET), polytrimethylene terephthalate, polyethylenenaphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI),polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide(PPO), poly paraphenylene terephthalamide (for example, KEVLAR®),polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMSAmerican Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinylalcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC),poly(styrene-b -isobutylene-b-styrene) (for example, SIBS and/or SIBS50A), polycarbonates, ionomers, biocompatible polymers, other suitablematerials, or mixtures, combinations, copolymers thereof, polymer/metalcomposites, and the like. In some embodiments the sheath can be blendedwith a liquid crystal polymer (LCP). For example, the mixture cancontain up to about 6 percent LCP.

Some examples of suitable metals and metal alloys include stainlesssteel, such as 304V, 304L, and 316LV stainless steel; mild steel;nickel-titanium alloy such as linear -elastic and/or super-elasticnitinol; other nickel alloys such as nickel-chromium -molybdenum alloys(e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY®C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys,and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL®400, NICKELVAC® 400, NICORROS® 400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and thelike), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY®ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenumalloys, other nickel-cobalt alloys, other nickel-iron alloys, othernickel-copper alloys, other nickel-tungsten or tungsten alloys, and thelike; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g.,UNS: R30003 such as ELGILOY®, PHYNOX®, and the like); platinum enrichedstainless steel; titanium; combinations thereof; and the like; or anyother suitable material.

In at least some embodiments, portions or all of the stents, and othercomponents of the stents described herein, may also be doped with, madeof, or otherwise include a radiopaque material. Radiopaque materials areunderstood to be materials capable of producing a relatively brightimage on a fluoroscopy screen or another imaging technique during amedical procedure. This relatively bright image aids users indetermining the stent’s location. Some examples of radiopaque materialscan include, but are not limited to, gold, platinum, palladium,tantalum, tungsten alloy, polymer material loaded with a radiopaquefiller, and the like. Additionally, other radiopaque marker bands and/orcoils may also be incorporated into the design of the stents to achievethe same result.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI)compatibility is imparted into the stents described herein. For example,stents and other components of the stents, or portions thereof, may bemade of a material that does not substantially distort the image andcreate substantial artifacts (e.g., gaps in the image). The stents mayalso be made from a material that the MRI machine can image. Somematerials that exhibit these characteristics include, for example,tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such asELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenumalloys (e.g., UNS: R30035 such as MP35-N® and the like), nitinol, andthe like, and others.

Some embodiments may be described using the expression “coupled” and“connected” along with their derivatives. These terms are not intendedas synonyms for each other. For example, some embodiments may bedescribed using the terms “connected” and/or “coupled” to indicate thattwo or more elements are in direct physical or electrical contact witheach other. The term “coupled,” however, may also mean that two or moreelements are not in direct contact with each other, but yet stillco-operate or interact with each other.

As used herein, the singular forms “a,” “an,” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprises”and/or “comprising,” or “includes” and/or “including” when used herein,specify the presence of stated features, regions, steps elements and/orcomponents, but do not preclude the presence or addition of one or moreother features, regions, integers, steps, operations, elements,components and/or groups thereof.

Furthermore, the terms “substantial” or “substantially,” as well as theterms “approximate” or “approximately,” can be used interchangeably insome embodiments, and can be described using any relative measuresacceptable by one of skill. For example, these terms can serve as acomparison to a reference parameter, to indicate a deviation that willstill provide the intended function. Although non-limiting, thedeviation from the reference parameter can be, for example, in an amountof less than 1%, less than 3%, less than 5%, less than 10%, less than15%, less than 20%, and so on.

Although specific embodiments have been illustrated and describedherein, it should be appreciated that any arrangement calculated toachieve the same purpose may be substituted for the specific embodimentsshown. This disclosure is intended to cover any and all adaptations orvariations of various embodiments. It is to be understood that the abovedescription has been made in an illustrative fashion, and not arestrictive one. Combinations of the above embodiments, and otherembodiments not specifically described herein will be apparent to thoseof skill in the art upon reviewing the above description. Thus, thescope of various embodiments includes any other applications in whichthe above compositions, structures, and methods are used.

Still furthermore, although the illustrative method 1600 is describedabove as a series of acts or events, the present disclosure is notlimited by the illustrated ordering of such acts or events unlessspecifically stated. For example, some acts may occur in differentorders and/or concurrently with other acts or events apart from thoseillustrated and/or described herein, in accordance with the disclosure.In addition, not all illustrated acts or events may be required toimplement a methodology in accordance with the present disclosure.

Although the subject matter has been described in language specific tostructural features and/or methodological acts, it is to be understoodthat the subject matter defined in the appended claims is notnecessarily limited to the specific features or acts described above.Rather, the specific features and acts described above are disclosed asexample forms of implementing the claims.

What is claimed is:
 1. A stent, comprising: a tubular scaffold having alongitudinal extent with a first end opposite a second end and ananchoring region at an anchoring position along the longitudinal extent,and defining a lumen extending between the first end and the second end;and a liner extending at least partially along the tubular scaffold;wherein: the anchoring region of the tubular scaffold has a shapedistinct from the shape of a region of the tubular scaffold proximal tothe anchoring region and a region of the tubular scaffold distal to theanchoring region; and a portion of the liner located along thelongitudinal extent of the tubular scaffold at the same position as theanchoring position is spaced radially-inwardly from and within theanchoring region of the tubular scaffold to promote tissue ingrowth withthe anchoring region of the tubular scaffold.
 2. The stent of claim 1,wherein the anchoring region is a medial anchoring region along themedial section of the scaffold to promote tissue ingrowth with themedial section.
 3. The stent of claim 2, wherein the medial anchoringregion is provided at an expanded portion of the medial section, andwherein the expanded portion has a diameter greater than a diameter ofthe medial section.
 4. The stent of claim 3, wherein the liner isradially-inwardly spaced from and within the expanded portion to promotetissue ingrowth with the expanded portion.
 5. The stent of claim 1,wherein the anchoring region is located along a sloped portion of aflared section of the tubular scaffold, and wherein the sloped portionextends away from a central longitudinal axis extending through thelumen.
 6. The stent of claim 1, wherein the medial section has asubstantially uniform diameter.
 7. The stent of claim 1, wherein: thetubular scaffold comprises a flared section and a medial sectionextending longitudinally from the flared section; and the anchoringregion is located along the flared section.
 8. A system, comprising: astent comprising: a tubular scaffold having a longitudinal extent with afirst end opposite a second end and an anchoring region along thelongitudinal extent, and defining a lumen extending between the firstend and the second end; and a liner extending at least partially alongthe tubular scaffold, wherein a portion of the liner located along thelongitudinal extent of the tubular scaffold at the same position as theanchoring region of the tubular scaffold is spaced radially-inwardlyfrom and within-the anchoring region to promote tissue ingrowth with theanchoring region and between the regions of the tubular scaffoldproximal and distal to the anchoring region; and a sheath extending fromthe second end of the tubular scaffold, the sheath having a proximal endopposite a distal end, wherein a lumen extends between the proximal endand the distal end.
 9. The system of claim 8, further comprising asecond stent coupled to the distal end of the sheath.
 10. The system ofclaim 9, the second stent comprising: a second tubular scaffold; and asecond liner extending partially along the second tubular scaffold. 11.The system of claim 10, wherein: the first tubular scaffold comprises aflared section and a medial section extending longitudinally from theflared section; the second tubular scaffold comprises a flared sectionand a medial section extending from the flared section; and the linerextending at least partially along the tubular scaffold is spaced fromand within an anchoring region along the flared section of the tubularscaffold to promote tissue ingrowth with the anchoring region.
 12. Thesystem of claim 8, wherein the anchoring region is a medial anchoringregion along the medial section of the scaffold to promote tissueingrowth with the medial section.
 13. The stent of claim 8, wherein theanchoring region is located along a sloped portion of a flared sectionof the tubular scaffold, and wherein the sloped portion extends awayfrom a central longitudinal axis extending through the lumen.
 14. Thestent of claim 8, wherein the medial section includes an expandedportion, the expanded portion having a diameter greater than a diameterof the medial section.
 15. The stent of claim 14, wherein the liner isradially-inwardly spaced from and within the expanded portion to promotetissue ingrowth with the expanded portion.
 16. The stent of claim 8,wherein the sheath comprises a structural support element.
 17. A method,comprising: deploying a system within a gastrointestinal (GI) tract of apatient, the system comprising: a stent comprising a tubular scaffoldhaving a longitudinal extent with a first end opposite a second end andan anchoring region at an anchoring position along the longitudinalextent, and defining a lumen extending between the first end and thesecond end; and a liner extending at least partially along the tubularscaffold, wherein a portion of the liner located along the longitudinalextent of the tubular scaffold at the same position as the anchoringposition is spaced radially-inwardly from and within the anchoringregion of the tubular scaffold such that the anchoring region is exposedto the GI tract to promote tissue ingrowth between the anchoring regionof the tubular scaffold and the GI tract; and positioning the tubularscaffold in the GI tract with the anchoring region of the tubularscaffold adjacent tissue in the GI tract to promote tissue ingrowththerewith.
 18. The method of claim 17, further comprising determining alocation of the GI tract target site, wherein the GI tract target sitecorresponds to a leak of the GI tract.
 19. The method of claim 17,further comprising bypassing a portion of the GI tract using a sheathextending from the second end of the tubular scaffold, the sheath havinga proximal end opposite a distal end, wherein a lumen extends betweenthe proximal and distal ends.
 20. The method of claim 19, furthercomprising securing a second stent within the GI tract, the second stentcoupled to the distal end of the sheath.